Retrovir (Zidovudine) - Summary

RETROVIR SUMMARY

RETROVIR®
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup

RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against human immunodeficiency virus (HIV).

RETROVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.

Maternal-Fetal HIV Transmission: RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).

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NEWS HIGHLIGHTS

Media Articles Related to Retrovir (Zidovudine)

Reminders By Text Messages Help HIV Patients Stick To Antiretroviral Drug Therapy
Source: Compliance News From Medical News Today [2012.03.14]
Mobile phones could play a valuable role in helping HIV patients to take their medication every day, according to a new Cochrane Systematic Review. The researchers found that patients were less likely to miss doses if they were sent weekly mobile phone text message reminders...

Compliance By African-Americans To HIV Therapy Problematic, Untreated Depression Makes It Worse
Source: Compliance News From Medical News Today [2012.05.04]
African-Americans with HIV are much less likely to adhere to drug therapy than others with the disease, according to a University of Michigan study. Moreover, untreated depression may greatly hinder adherence to antiretroviral therapy (ART) for all low-income, HIV-infected patients, regardless of race...

Breastfeeding For Longer Plus Extended ART May Reduce Mother-To-Child HIV Transmission
Source: HIV / AIDS News From Medical News Today [2012.04.27]
Long-term results of the Breastfeeding, Antiretrovirals, and Nutrition (BAN) randomized trial reveals that breastfeeding for a longer period along (6+ months) with antiretroviral therapy (ART) could help reduce mother-to-child HIV transmission as well as improve chances of infant's survival...

Study Results Presented At Microbicides 2012 - No Added HIV Risk With Hormonal Contraceptives
Source: Sexual Health / STDs News From Medical News Today [2012.04.18]
An HIV prevention trial that pre-dates the shift to antiretroviral (ARV)-based approaches is nonetheless helping to answer some of the most relevant and topical questions the field is facing today...

When HIV Patients Waver On Meds
Source: Nursing / Midwifery News From Medical News Today [2012.02.06]
According to a new analysis of hundreds of recorded office visits, doctors and nurse practitioners typically issued orders and asked closed or leading questions when talking to their HIV-positive patients about adherence to antiretroviral therapy. Attempts at problem-solving with patients who had lapsed occurred in less than a quarter of visits. Take your medicine, Doctor's orders...

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Published Studies Related to Retrovir (Zidovudine)

A randomized trial of punctuated antiretroviral therapy in Ugandan HIV-seropositive adults with pulmonary tuberculosis and CD4 T-cell counts of >/= 350 cells/muL. [2011.09.15]
BACKGROUND: Optimal treatment of human immunodeficiency virus (HIV)-associated tuberculosis in patients with high CD4 T-cell counts is unknown. Suppression of viral replication during therapy for tuberculosis may block effects of immune activation on T cells and slow HIV disease progression... CONCLUSIONS: Short-term antiretroviral therapy during tuberculosis treatment in patients with CD4T-cell counts of >350 cells/muL was safe and associated with clinical benefits.

Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. [2011.08.01]
BACKGROUND: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009... CONCLUSIONS: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ~70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.

Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)--associated tuberculous meningitis. [2011.06]
BACKGROUND: The optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-associated tuberculous meningitis is unknown... CONCLUSIONS: Immediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis. Clinical Trials Registration. ISRCTN63659091.

Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. [2011.06]
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects... Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.

Challenges in PMTCT antiretroviral adherence in northern KwaZulu-Natal, South Africa. [2011.06]
BACKGROUND: Women living with HIV in sub-Saharan Africa face significant challenges in accessing HIV care and adhering to antiretroviral therapy. Most reports have focused on issues relating to long-term adherence such as those surrounding stigma and disclosure, hunger, cultural factors, lack of accurate health information, lack of social support, medication side effects and overcrowded health systems. Information related to the challenges facing pregnant women when taking antiretrovirals for prophylactic purposes is limited. The "Kesho Bora Study" is a multicentre prevention of mother-to-child transmission (PMTCT) trial in sub-Saharan Africa evaluating the PMTCT efficacy of triple therapy until cessation of breast feeding compared to short course zidovudine monotherapy in a predominantly breast feeding population. Following unexplained discrepancies during objective adherence assessments, a sub-study was conducted at one site to examine the underlying adherence issues... CONCLUSION: Antenatal women in northern rural KwaZulu-Natal face significant challenges in taking antiretroviral PMTCT prophylaxis.

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Clinical Trials Related to Retrovir (Zidovudine)

Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1. 6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.

A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection [Completed]
Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i. e., CD4 counts return to >= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only.

Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e. g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.

Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma [Recruiting]
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep the cancer cell from growing.

PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic virus type 1-associated adult T-cell leukemia/lymphoma.

A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell [Completed]
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.

SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.

A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases [Completed]
The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.

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